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TemporaryFDAOngoing

Can cause harm that is usually temporary.

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

Check the device or its packaging for

Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
Why
Potential for false negative patient results.
Distributed
Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
Company
DRG International, Inc.
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Source: FDA record Z-0082-2027 · retrieved 2 October 2026

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